Evaluating human papillomavirus (HPV) self‐sampling among Latinas in the United States: A systematic review

Abstract Background Latinas experience the greatest cervical cancer incidence compared with other ethnic/racial groups in the United States (US) due in part to significant disparities in screening uptake. Social and structural conditions that impede access to and participation in screening include language barriers, concerns about documentation status, logistical issues (e.g., transportation, limited clinic hours), and cultural beliefs regarding modesty and promiscuity. To overcome these challenges, self‐sampling for human papillomavirus (HPV) DNA testing has emerged as a potentially promising method for promoting cervical cancer screening among this population. Thus, this systematic review aimed to assess the acceptability of HPV self‐sampling among US Latinas. Methods Using EBSCOhost and PubMed databases, we searched for studies published in the past two decades (2003–2023) that described participation in HPV self‐sampling among Latinas. Eleven articles met inclusion criteria. Results The majority of studies were conducted in Florida, California, and Puerto Rico, were single‐arm designs, and involved the use of community health workers and Spanish‐language materials (e.g., brochures). Across studies, the majority of participants reported that self‐sampling was acceptable with respect to ease of use, comfort (lack of pain), privacy, and convenience; however, some women were concerned about the accuracy of self‐sampling or whether they had performed sample collection correctly. Conclusion Given the high acceptability, self‐collection of cervicovaginal samples for HPV testing may offer a feasible option for enhancing participation in cervical cancer screening in this population that encounters significant barriers to screening.


| INTRODUCTION
Due to advances in the early detection and prevention of cervical cancer, deaths from cervical cancer are declining.However, not all groups are benefitting equally from these advances.Notably, cervical cancer incidence remains 32% higher among Latina women in the continental United States (US) and 78% higher among women in Puerto Rico (a US territory) compared with non-Hispanic White (NHW) women. 1 National statistics report that cervical cancer incidence rates are 9.3/100,000 among Latinas compared to 6.7/100,000 among NHW women.Although cervical cancer mortality rates have declined by ~35% from 1990 to 2019 across both groups, Latinas still experience higher death rates and are 30% more likely to die from cervical cancer than NHW women (2.0/100,000). 1 Cervical cancer is a highly preventable disease, largely due to effective screening tests and the development of a vaccine against high-risk human papillomavirus (HPV).The US Preventive Services Task Force (USPSTF) recommends routine cervical cancer screening for women between the ages of 21 and 65. 2 Yet, despite having one of the highest incidence rates of cervical cancer, Latinas are significantly less likely to participate in cervical cancer screening compared with NH White and Black women. 3As of 2021, 67.9% of Hispanic women, compared to 75.7% of NHW women, reported being up to date with current cervical cancer screening guidelines. 4Furthermore, only 87% of Hispanic women report ever having had a pap smear, compared to 94% of NHW women. 5Previously identified barriers to screening include: language barriers, lack of access to care or limited clinic hours, racism and discrimination, inadequate knowledge, preference for race/ethnic concordant providers, and cultural concerns regarding modesty. 6,7Peer approaches and community-driven interventions may be successful in establishing trust and providing education about screening, 8 but structural barriers (e.g., inconvenience of clinic hours) and limited access remain formidable challenges to overcome and are not easily addressed with traditional health promotion programs.
8][19][20][21] Convenience of self-sampling is reported to be a key advantage of self-sampling, 22 particularly among those who report that it is difficult to obtain clinic-based screening due to a lack of time or inflexible clinic hours. 23imply expanding access to these tools, however, may be insufficient to promote participation and interest in screening.5][26] Often hailing from historically underrepresented groups, CHWs not only bring valuable cultural and linguistic insights that foster trust and rapport within their communities, but also are trained to bridge gaps in access to care and empower individuals to make informed decisions about their health. 27In fact, a recent study found that CHW-facilitated self-sampling may be useful for mitigating multilevel barriers to cervical cancer screening among Latina women. 28As a result, the integration of CHWs with self-sampling options may enhance the acceptability and efficacy of this strategy for promoting cervical cancer screening.
National guidelines now include primary HPV screening every 5 years as an evidence-based cervical cancer screening strategy for women ages 30-65, and it was given an "A" recommendation by the USPSTF. 2 Because selfsampling for HPV testing in non-clinical settings has comparable accuracy to HPV-testing on clinician-obtained samples, [12][13][14][15][16] the USPSTF suggests that "…self-collection may be one strategy for increasing screening rates among populations where they are currently low." 2 Hence, HPV self-sampling may offer a feasible and efficient approach for significantly increasing screening coverage among Latinas, a population that has traditionally had lower cervical cancer screening rates than other groups.However, the acceptability of this approach among Latina women in the United States has not been systematically evaluated.Thus, the present paper aims to review published studies that examined self-sampling approaches for cervical cancer screening in US Latina women.

| MATERIALS AND METHODS
We conducted this systematic review according to the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines, 29 which ensures the highest standard in systematic reviewing.The articles were identified by the authors and the librarians at the University of Central Florida College of Medicine and were evaluated independently, as described below.

| Search strategy
Four sets of search strings were built based on the following concepts: (1) cervical cancer screening, (2) selfsampling, (3) Hispanic community, and (4) programs or interventions.The publication year filter was used to narrow down studies between 2003 and 2023.This date range was selected because HPV DNA testing (combined with a Pap test) was first included in US screening guidelines starting in 2003. 30The search was conducted using EBSCOhost (which contains 91 databases) and PubMed.In addition to the authors, the search was supported by two University of Central Florida College of Medicine librarians.Upon their initial search, the librarians identified a dearth of clinical trials focused on HPV self-sampling among underserved populations, particularly Latinas.Thus, the librarians helped to expand the inclusion and exclusion criteria search terms for the literature search.See Table S1 for the comprehensive list of search terms used.

| Inclusion criteria
To broadly identify research on the acceptability of selfsampling in the context of cervical cancer screening among US Latinas, studies were included if they: (1) were published between January 2003 and August 2023, (2)  were conducted in the US, (3) included self-collection of a cervical or vaginal sample, (4) enrolled participants who self-identified as Hispanic or Latina, (5) reported acceptability or uptake of self-sampling, and (6) were published in English or Spanish.Articles were excluded if they: (1) focused exclusively on the concordance of HPV DNA test results between self-collected and clinician-collected samples; (2) were review papers, commentaries, or protocol/ methods papers; or (3) did not include a study sample that was comprised of at least 10% of participants who selfidentified as Hispanic or Latina.

| Screening process and data extraction
The review procedure included the following steps: (1) First, two reviewers independently screened each paper title and abstract for eligibility.(2) Relevant articles were then selected for full-length review.(3) Studies included in the full-length review underwent data extraction, with one reviewer completing the extraction of key study elements and the other reviewer appraising for accuracy.Disagreements at each stage were discussed among all authors until consensus was achieved.Key study elements within the standardized extraction template included the location of the study (where the study was conducted), study purpose, sample size (including the proportion of Latina participants), mean participant age, self-sampling device(s) used, description of the study procedure(s) or intervention(s), study length, any cultural components, and main acceptability and uptake outcomes.

| RESULTS
The database search yielded 146 citations.After removing duplicates, the remaining 103 studies were subjected to title and abstract review.Twenty studies were assessed at full length, of which 11 were included in the systematic review.See Figure 1 for Flow Diagram.

| Study characteristics
Sample sizes ranged from 100 to 1213 participants; all studies except one 31 had 601 or fewer participants.Two studies were published between 2005 and 2008, five between 2012 and 2016, and four between 2018 and 2023.No studies published between 2009 and 2011 met the inclusion criteria.Multiple studies were conducted in southern Florida (n = 3), California (n = 2), and Puerto Rico (n = 2).Other study locations included New York, North Carolina, Texas, and the U.S.-Mexico Border (state not specified).[37][38][39][40][41] See Table 1 for additional description of the Study Characteristics.

| Study participants and recruitment
Because national guidelines for cervical cancer screening are updated regularly, inclusion criteria for previous cytology testing varied across studies.Four studies included women who had not had a Pap test in the last 3 years, 32,33,37,38 two others restricted the criteria to a single year, 31,34 the remaining did not specify 35,41 or had some other criteria. 36,39,40Seven of the studies recruited participants in either a clinical setting [34][35][36][37]39,40 or community health organization 38 ; the remaining four studies recruited participants from non-clinical settings, [31][32][33]41 which included community organizations, churches, and participants' homes. The mjority of studies 31,34,35,37,38,40,41 had samples that included 74% or greater identify as Hispanic or Latina.Two studies 32,33 recruited samples that included between 59% and 65% Hispanic or Latina participants; and only two studies 36,39 reported that Hispanic participants comprised a minority of the study sample (between 14% and 29%). Th age of participants ranged from 16 to 65 years.

Considerations
Culturally tailored materials can enhance participant engagement and accommodate culture-specific values and language preferences.Six studies described how materials were adapted for the Latino population through focus groups, 34,35 pilot-testing, 32,34,41 feedback from community partners, 32,33 or with the assistance of CHWs familiar with the community. 37Eight studies 31,33,[35][36][37][38]41,42 explicitly stated that study materials and information were provided in Spanish. Thesematerials included informational brochures, presentations, and study assessments.Two other studies 34,39 did not explicitly mention language, and the remaining study 40 was assumed to be available in Spanish since it was conducted in Puerto Rico.
Additionally, the use of theoretical frameworks allows for the comprehensive integration of cultural values throughout study materials and procedures, as opposed to mere language adaptation.However, only three articles included a description of how theoretical frameworks were used to guide study content or procedures.Carrasquillo et al. 42 utilized Community-Based Participatory Research (CBPR) principles.They worked closely with two community partners, one being a Federally Qualified Health Center, through all phases of the intervention.Similarly, Kobetz et al. 43 utilized the Socio-Ecological Model to orient their CBPR approach.Finally, the educational presentation provided to participants in Penaranda et al. 35 was guided by selected constructs from the Health Belief Model (e.g., perceived severity).

| Self-sampling setting and device(s)
Five studies [31][32][33]35,37 utilized community health workers (CHW) in study procedures. In tw of these studies, 35,37 the CHW operated within a clinical setting; in the remaining three studies, CHWs conducted activities in nonclinical settings (e.g., participant's home).[31][32][33] Seven studies involved self-collection of samples at a clinic [34][35][36][37]39,40 or community health location, 38 and four studies were conducted in the participant's home 41 or utilized an agreed-upon community location (which could be the participant's home).[31][32][33] Only two of the studies 33,39 asked participants to mail samples back; in all of the other studies, participants returned their self-collected sample(s) in person.
All of the studies included a device for cervico-vaginal self-collection, such as a swab or brush that can be inserted into the vaginal canal.In addition, one study also collected menstrual blood using modified pads, 39 and several studies collected anal samples, 40 urine samples, 36 and oral and anal samples. 41In five of the studies, a cliniciancollected sample was also obtained. 31,34,36,39,40T A B L E 1 (Continued)

| Self-sampling acceptability
The studies used varied measures to assess women's acceptability of self-sampling.Two studies assessed the acceptability of HPV self-sampling only, with no comparison to physician sampling or other forms of sampling. 37,38In these studies, Latina participants expressed very favorable opinions of self-sampling, with 83%-99% reporting that self-sampling was easy to perform.Further, when asked to state a preference for self-sampling or a clinician-performed Pap test, 89% of Latina participants indicated that they would choose self-sampling over a clinician-administered Pap test in the future. 37Women reported that ease of use, convenience, and privacy were major factors contributing to high acceptability of self-sampling. 37,38hree studies assessed women who underwent both self-sampling and had a Pap test performed by a clinician. 31,34,35One of the three studies was comprised entirely of Latina participants, and the majority (81.8%) rated the ease of use and convenience of self-sampling over clinician sampling as excellent or very good. 31The other two studies had mixed study samples comprised of at least 76% Latina participants 34,35 ; in these studies, the majority of participants (which included some non-Latina women) reported that self-sampling was easy to perform (100% 35 and 69% 34 ).Among women residing along the U.S.-Mexico border (of which 87% were Latina), acceptability of self-sampling was rated higher than for a clinician-administered Pap test, and all participants reported that self-sampling was easy and convenient.When asked to express a preference, 30% stated a preference for self-sampling, 26% preferred a clinician-administered Pap test, and 42.7% expressed no preference. 35The third study reported that only 28% of Latina participants preferred self-sampling to cliniciancollected sampling procedures, 34 due to concerns that self-sampling is less sensitive or accurate than a cliniciancollected sample, even though self-sampling was acceptable to the majority of women.The findings from this study may also differ from the other published studies because all study participants were recruited from either a clinic for sexually transmitted diseases (STDs) or from a cancer screening clinic and had been screened for cervical cancer within the past 3 years.Further, the authors noted that preferences for self-sampling differed across clinic sites, with women presenting at a cancer screening clinic expressing greater desire for a clinician-administered test and lower preferences for a home-based option that did not require "coming in for an appointment" compared to women who were recruited from the STD clinic. 34Thus, among screening-adherent women who are motivated to seek care specifically at a cancer screening clinic, the option to self-collect one's own sample may be perceived to be less accurate or more likely to potentially 'miss' a cancer compared to a clinician-administered test.
0][41] Two of these studies were conducted in Puerto Rico and had study samples that included over 88% Latina participants.In these studies, women preferred self-collection of vaginal samples to physician-collected sampling. 40,41However, collection of oral rinse samples was preferred to vaginal sampling. 41The two remaining studies also reported preferences for self-sampling over clinician-sampling, 36,39 although these studies included only a minority of Latina or Hispanic participants.However, subgroup analyses of Hispanic women only revealed that the majority reported positive feelings toward urine self-collection (81%) and cervico-vaginal selfsampling (71%). 36nly two studies utilized a randomized trial design, and both of these were conducted in South Florida with over 59% Latina participants (the remainder was comprised of Haitian and non-Hispanic Black participants).Results were reported across the entire sample.In brief, a greater proportion of women provided with a self-sampling option completed cervical cancer screening (77%) compared to women randomized to outreach only (which included a brochure about screening and information on where to obtain a Pap test; 31%) or to CHW-led education and navigation to a clinic for a Pap test (43%). 32A subsequent randomized trial evaluated whether delivering self-sampling kits in-person was superior to a mailed kit. 33Completion of self-sampling was slightly higher when delivered inperson by a CHW (81%) compared to delivered via US mail (71.6%). 33Acceptability was not directly measured in either study, but it can be inferred from the high completion rates that women were comfortable with self-sampling and deemed it to be an acceptable option.

| DISCUSSION
This is the first systematic review of the acceptability of HPV self-sampling among U.S. Latina women.Despite the different methodologies used across studies, our findings indicate that acceptability of self-sampling is high in this population, with women reporting that self-sampling is easy to perform and convenient, offers greater privacy, and is less embarrassing to undergo than a clinical exam.The primary disadvantage of self-sampling that was reported was the fear that one was not collecting the sample correctly. 34Clinician-collected samples were perceived to be more accurate amid this concern.Finally, although cervico-vaginal self-sampling was acceptable to women, the collection of other samples (e.g., oral rinse, urine, menstrual blood) was preferred to vaginal sampling. 36,39,41ur findings are consistent with those reported in other populations.A systematic review of studies conducted across 24 countries also indicated high acceptability of self-sampling, with women reporting a greater preference for self-sampling over clinician sampling due to its ease and convenience. 44A more recent review of women's values and preferences around self-sampling also revealed key preferences for setting, with the ability to collect one's sample at home being preferable to self-collecting one's sample at a clinic due to these same reasons (ease, convenience, and privacy). 45In the present review, we did not observe any distinct patterns in preference for selfsampling by setting (clinic vs. home); however, the location of self-collection was not always specified or it was variable even within a particular study (e.g., self-sampling could be performed at the participant's home or other convenient location).
Since most studies had the potential to be completed within a single interaction with research or healthcare staff, there were limited opportunities to provide more comprehensive education and information about cervical cancer risk and the benefits of screening and early detection, which is a potential disadvantage of this approach.Indeed, delivery of educational content was not a primary focus in many of the studies.If offered, the educational information provided was brief and did not allow for repetition of the material in multiple instances.In studies where educational information was provided, it was delivered by CHWs and/or with Spanish-language materials, which underscores the need to utilize culturally-and linguistically-appropriate methods for engaging this population.Although it is acknowledged that the addition of CHWs or health education content could lead to greater burden (i.e., longer visits), recent studies offer some potential strategies to consider. 46For example, 52% of medically underserved women (including Latina women) reported that they would be willing to participate in social-media interventions about HPV self-testing. 46Similarly, a recent systematic review reported that video interventions can be effective in increasing cervical cancer screening broadly. 47urther, video interventions that were culturally tailored were more effective in promoting screening uptake compared to those that provided information only. 47t present, the cost-effectiveness of implementing a broad self-sampling program for cervical cancer screening in this population is unclear.Additional research is needed to assess the cost-benefit ratio for delivering such programs over the long-term.Future studies should also prioritize rigorous follow-up with participants.Given that some women may not be eligible to participate in available government-funded programs due to immigration status or other factors, finding sufficient support for follow-up care remains a persistent challenge. 48This may necessitate setting aside additional resources to help underserved women obtain medical and financial assistance for diagnostic healthcare services. 49,50It may also require expanding the eligibility criteria for state and/or federallyfunded programs that provide low-cost cancer screening and treatment services for underserved women.
Finally, it is acknowledged that offering a self-sampling option for cervical cancer screening is not intended to replace attendance at routine care visits with one's healthcare provider.Rather, the goal is to promote women's active engagement in their preventive care and to increase acceptance of screening.Qualitative data in other samples suggest that self-sampling may help achieve these goals, especially since some women have reported feeling less embarrassed about screening following the performance of self-collection. 51Other indirect benefits that may result from self-sampling include increasing women's comfort and autonomy with their bodies, emphasizing the importance of screening for maintaining good health, and reducing embarrassment associated with gynecologic exams in general. 51,52trengths of this review include the use of multiple databases to identify a comprehensive list of articles and the inclusion of studies published in Spanish or English.However, some limitations should be noted.First, nine studies included women who had been screened in the past 3 years for cervical cancer, were recruited at or through a clinic, or had previously tested positive for HPV-indicating a potential sampling bias.Since these participants already had access to healthcare and/or demonstrated health-seeking behaviors, they may not be representative of unscreened or underscreened women.Thus, the acceptability of self-sampling may be higher in these samples that have healthcare access or experience with cancerscreening behaviors.Second, most studies were single-arm studies (in which all participants underwent all study procedures); only two studies utilized a randomized trial design.Therefore, it is difficult to evaluate whether uptake of self-sampling would vary across conditions or settings.Third, most studies were descriptive in nature and had modest sample sizes or reported overall findings across a mixed sample of both Latina and non-Latina participants, which limits the extent to which we can draw definitive conclusions about the acceptability of self-sampling approaches in the US Latina population.The ability to disaggregate data across Hispanic/Latino subpopulations is also critically needed in future studies as various factors (e.g., immigration status, English language proficiency) that differ across subgroups likely also contribute to women's willingness to participate in self-sampling and cervical cancer screening. 53Finally, the concentration of studies in Florida, California, and Puerto Rico highlights specific regional initiatives tailored to the needs of Latinas in those areas; but given the large population of Latina residents across Texas, New York, and Arizona, 54 it may be fruitful to expand studies across a broader region.Overall, however, the findings from this systematic review suggest that selfsampling approaches for cervical cancer screening may offer a promising option to consider for future clinical research involving this population.

| CONCLUSION
Providing alternatives to clinic-based cervical cancer screening are acceptable and could enhance screening participation and engagement among underscreened US Latinas facing barriers to traditional screening.HPV selfsampling has emerged as a promising approach to address cervical cancer disparities by introducing evidence-based strategies for HPV DNA testing and increasing screening accessibility.This holds particular significance as Latinas encounter distinct barriers to care including language obstacles, difficulties in accessing care, and experiences of racism and discrimination.Findings from this systematic review offer guidance for future clinic-and communitybased programs aimed at increasing participation in recommended cervical cancer screening, with the ultimate goal of eliminating disparities in cervical cancer and enhancing women's health.

F I G U R E 1
Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram of search results.Title and abstract screened (n = 103) Full papers assessed for eligibility (n = 20) Studies included in the review (n=11) Removed duplicate records (n=43) Did not meet inclusion criteria (n = 83) • Not conducted in the US (n=54) • No self-sampling (n=13) • Review papers or perspectives (n=9) • Limited/no Hispanic/Latina participants (n=3) • Assessed oral HPV and periodontitis (n=2) • HPV concordance only, no acceptability data (n=2) Did not meet inclusion criteria (n = 9) • Not conducted in the US (n=2) Characteristics of studies included in the review.
T A B L E 1 Abbreviations: CHW, Community Health Worker; IP, in-person; POI/NIH, Preventive Oncology International/National Institute of Health; SS, self-sampling.a Results represent the proportion of the specified Latina or Hispanic sample.b Results represent the proportion of the whole (mixed) sample.